HHS Expands Innovation Partnerships with Private Sector

DRIVe initiative makes deeper forays into innovations that could help predict illness and enhance sepsis detection.

The U.S. Department of Health & Human Services (HHS) is on an innovation whirlwind these days, announcing multiple technology investments and initiatives through the Division of Research, Innovation, and Ventures (DRIVe) to help detect exposure to pathogens before signs of illness develop, as well as a more efficient and effective means to diagnose sepsis.

The two latest innovation partnerships involve adapting a smart wristband—already FDA-cleared for seizure detection—to predict illness from pathogen exposure, plus new technology to diagnose infection in patients who may have sepsis, which delivers assay results in 60 minutes.

DRIVe's business model requires companies to share in the investment to further develop their products. The government organization, which was launched June 2018 by the Biomedical Advanced Research and Development Authority (BARDA), has invested $5,725,162 to date; partnering companies have invested $5,179,802.98. BARDA operates under the auspices of the HHS Assistant Secretary for Preparedness and Response.

Empatica's Smartband Already FDA-Approved for Seizure Detection
 

Empatica of Cambridge, Massachusetts, is the latest firm to join the DRIVe portfolio in a quest to develop a smartband which will monitor physiological indicators and employ machine learning to warn users they are getting sick before symptoms are present. The project builds on Empatica’s Embrace2 device, a battery-powered, FDA-cleared wristband which detects patterns associated with tonic-clonic epileptic seizures and issues alerts to caregivers.

DRIVe is contributing $251,454 of the total $457,189 project cost, with Empatica providing the remainder. Empatica is a MIT Media Lab spinoff, developing wearable smartbands that utilize machine learning and an intricate combination of biosensors to unlock the physiology of health.

This initiative is part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio, which is developing products that inform people they are sick before the first symptom appears, encourage early treatment, and potentially reduce the spread of bacteria and viruses. DRIVe has funded similar products for development including:

• A wristwatch from Israeli company, Biobeat Technologies, which employs reflective photoplethysmography, a low-cost technique to detect blood volume changes in the smallest blood vessels of human tissue
   
• A wearable device from San Francisco-based Spire, which adheres to underwear and monitors bio-signals, such as heart-rate, breathing variability, and stress levels
   
• A wearable device that detects infections in sweat from EnLiSense, based in Allen, Texas

Qvella to Develop Test for Early Diagnosis of Sepsis
 

This week DRIVe also announced a partnership with Qvella Corporation of Carlsbad, California, to develop technology that will diagnose infection in patients suspected of sepsis and deliver assay results in 60 minutes.

The new host response diagnostic system leverages Qvella’s FAST-ID pathogen identification platform based on new approaches to rapid sample processing and nucleic acid isolation and amplification directly from whole blood, according to the news release. The Qvella project will combine the company’s diagnostics technology and expertise with Predigen Inc.’s gene signature analytical power to help develop the intended assay for the early diagnosis of sepsis.

DRIVe will contribute $692,236 of the total $988,909 estimated project cost with Qvella funding the remainder.

A Mission to Reduce the Impact of Sepsis
 

The Qvella partnership is part of the DRIVe Solving Sepsis initiative, designed to more rapidly and accurately diagnose sepsis and accelerate medical intervention to save lives, improve patient outcomes, and make better use of hospital facilities. HealthLeaders spoke to Rick A. Bright, PhD, deputy assistant secretary for Preparedness and Response and the director of BARDA, about the sepsis endeavor last June.

Other partners involved in Solving Sepsis include:

• Immunexpress of Seattle, Washington, to develop technology that analyzes a patient’s immune system to diagnose sepsis rapidly, within 90 minutes. The company's SeptiCyte technology is a precision diagnostic tool that evaluates a set of patented gene-expression biomarkers from the patient’s blood. The tool is being designed to use mathematical algorithms to differentiate sepsis and infection negative systemic inflammation and identify whether the sepsis infection is viral or bacterial.
   
• Emory University in Atlanta to further validate a machine learning algorithm that will attain FDA clearance for early prediction of sepsis in hospital intensive care units. The project involves a multicenter consortium, including Emory University School of Medicine, Massachusetts General Hospital, University of California San Diego School of Medicine, and Atlanta’s Grady Health System, for retrospective validation utilizing a secure cloud architecture and will also execute a prospective deployment of the real-time predictive algorithm.
   
• Cytovale, Inc. of San Francisco to develop new technology to diagnose sepsis in under 10 minutes. Using a simple blood test, Cytovale’s technology is intended to measure physical changes in immune cells that occur when someone is sick to indicate whether a patient has sepsis.
   
• InnaMed of Philadelphia, which is developing a point-of-care rapid blood testing device to help diagnose sepsis, determine risk stratification of patients, and monitor the response to treatments. The funding is intended to develop a promising biomarker associated with sepsis to be integrated into the portable device.
   
• Chicago-based Prenosis for validation of sepsis biomarker assays with the potential to incorporate into a point of care device.

DRIVe also recently announced a partnership with the Sepsis Alliance to launch the Sepsis Institute, an evidence-based sepsis education and training initiative to enhance the recognition, treatment, and management of sepsis for healthcare professionals. The Institute will develop webinars and training modules for primary care and urgent care practitioners, nursing staff, and emergency medical services personnel.